Effects of Home-based Respiratory Muscle Training Progamme in Individuals With Ischemic Heart Disease

Effects of Home-based Respiratory Muscle Training by Telerehabilitation on Quality of Life, Cardiopulmonary Function, Physical Status and Psychological Status in Individuals With Ischemic Heart Disease

The main objective of the present study is to verify whether respiratory muscle training programme (IMT+EMT; included both inspriratory and expiratory muscles), applied by telerehabilitation, is an effective intervention (versus placebo and versus inspiratory muscle training in isolation (IMT)) in improving quality of life, cardiopulmonary function and physical and psychological state in people with ischemic heart disease. In addition, the aim is to determine whether respiratory muscle training (IMT or IMT+EMT) is effective in enhancing the results obtained by a conventional cardiac rehabilitation programme on the aforementioned variables.

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Other: Inspiratory muscle training; Other: Conventional cardiac rehabilitation programme; Other: Sham inspiratory muscle training; Other: Combined inspiratory and expiratory muscle training; Other: Sham combined inspiratory and expiratory muscle training

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28040
      • Departamento de Radiología, Rehabilitación y Fisioterapia, Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Presence of ischemic heart disease
• Age 18 years or older
• Cardiovascular clinical stability

Exclusion Criteria:

• Any condition that contraindicate exercise training
• Inability to close the lips to hold the training device's mouthpiece (e.g., facial paralysis)
• Previous participation in a rehabilitation programme within the last 3 months
• Pregnancy
• Inability to adhere to remote monitoring

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inspiratory muscle training group + Exercise training; Participants in this group will perform a home-based inspiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)	Other: Inspiratory muscle training; Participants will engage in inspiratory muscle training programme at home using an inspiratory muscle training threshold device . This training will be conducted twice daily, five days a week, for eight weeks, with physiotherapist supervision provided three times per week by telerehabilitation.; Other: Conventional cardiac rehabilitation programme; Following the respiratory muscle training programme, participants will transition to a center-based cardiovascular exercise programme conducted twice weekly for eight weeks.
Sham Comparator: Inspiratory muscle training sham group + Exercise training; Participants in this group will perform a home-based sham inspiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)	Other: Conventional cardiac rehabilitation programme; Following the respiratory muscle training programme, participants will transition to a center-based cardiovascular exercise programme conducted twice weekly for eight weeks.; Other: Sham inspiratory muscle training; Participants will engage in sham inspiratory muscle training programme at home using a sham inspiratory muscle training threshold device . This training will be conducted twice daily, five days a week, for eight weeks, with physiotherapist supervision provided three times per week by telerehabilitation.
Experimental: Inspiratory and expiratory muscle training group + Exercise training; Participants in this group will perform a home-based inspiratory and expiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)	Other: Conventional cardiac rehabilitation programme; Following the respiratory muscle training programme, participants will transition to a center-based cardiovascular exercise programme conducted twice weekly for eight weeks.; Other: Combined inspiratory and expiratory muscle training; Participants will engage in inspiratory+expiratory muscle training programme at home using an inspiratory+expiratory muscle training threshold device . This training will be conducted twice daily, five days a week, for eight weeks, with physiotherapist supervision provided three times per week by telerehabilitation.
Sham Comparator: Inspiratory and expiratory muscle training Sham group + Exercise training; Participants in this group will perform a home-based sham inspiratory and expiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)	Other: Conventional cardiac rehabilitation programme; Following the respiratory muscle training programme, participants will transition to a center-based cardiovascular exercise programme conducted twice weekly for eight weeks.; Other: Sham combined inspiratory and expiratory muscle training; Participants will engage in sham inspiratory+expiratory muscle training programme at home using a sham inspiratory+expiratory muscle training threshold device . This training will be conducted twice daily, five days a week, for eight weeks, with physiotherapist supervision provided three times per week by telerehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life	EuroQol-five-dimensional Questionnaire A numerical value represented Health state as EQ-5D 'index values' or 'index scores' reflecting how good or bad a health state is. The VAS is a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).	Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Medical Research Council Dyspnoea Scale	The modified Medical Research Council (mMRC) assess the degree of functional disability due to dyspnoea. The mMRC breathlessness scale ranges from grade 0 to 4. Higher scores mean a worse dyspnoea.	Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Fatigue	Multidimensional Fatigue Inventory (MFI-17) The MFI is a valid and reliable instrument for assessing fatigue severity. It consists in 17 items ranked from 1 to 5, the maximun value is 85 points and the minimum 17 points. Higher scores mean a worse fatigue.	Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Cardiopulmonary function: level of exercise capacity	Exercise capacity will be measured using a Cardiopulmonary exercise testing (CPET) that precisely defines maximum exercise capacity through measurement of peak oxygen uptake. The following parameters will be acquired by breath-by-breath analysis using an automated gas analyzer: minute ventilation rate; oxygen consumption (VO2); carbon dioxide production (VCO2); and the other variables of to assess aerobic capacity and to identify potential limiting factors. An electrocardiogram and blood pressures will be recorded at rest, throughout exercise and during recovery.	Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Strength and endurance of the lower limbs	1 minute sit to stand	Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Upper limb strenght	Upper limb muscle strength (handgrip force) will be assessed using a hand-held dynamometer. Three measurements will be performed for each hand, alternating sides, with the elbow at 90° flexion. The best value will be recorded in kilogrames.	Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Respiratory muscle strength	Maximal inspiratory preassure and Maximal expiratory preassure	Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Inspiratory muscle endurance	Inspiratory muscle endurance will be assed by an incremental load test that required subjects to breathe against inspiratory threshold loads that were increased each minute by 10% of baseline PI,max until voluntary task failure muscle endurance test. Inspiratory muscle endurance was defined as the PI,max sustained for a minimum of 1 min.	Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Anxiety and depression levels	The Hospital Anxiety and Depression Scale (HADS) is a self-assessment questionnaire for detecting states of anxiety and depression. The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level.	Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: Instituto de Salud Carlos III; Hospital Universitario 12 de Octubre; European Regional Development Fund; Instituto de Investigación Sanitaria Hospital Clínico San Carlos

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Actual): February 6, 2026
• Study Completion (Actual): February 6, 2026

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Telerehabilitation; Cardiac rehabilitation; Respiratory muscle training; cardiopulmonary function; physical state; psychological state
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia
• Other Study ID Numbers: PI23/00816

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No